The Food and Drug Administration (FDA) has cleared several mobile medical applications (mobile medical apps) through the 510(k) process and is taking action that is expected to further impact a variety of industries developing, marketing and selling products used in a mobile health environment. The FDA’s Draft Guidance for Industry and Food and Drug Administration Staff- Mobile Medical Applications, initially released in July 2011, is expected to issue in final form in early 2012. (Food and Drug Administration, Draft Guidance for Industry and FDA Staff, Mobile Medical Applications, 21 July 2011 — hereinafter Draft Guidance.) The draft document describes how the Agency intends to apply its regulatory authority to the rapidly growing area of mobile apps and outlines a targeted group of mobile medical apps over which it intends to exercise regulatory oversight, with a focus on those mobile apps that present the greatest potential risk to patients if they do not work as intended. Notwithstanding certain ambiguities, the draft guidance provides useful information, including a lengthy appendix, and is, for now, the best source of the FDA’s current thinking on the topic. Highlights are set forth below.
Mobile medical apps — regulated, not regulated or subject to FDA discretion
According to the draft guidance, the Agency intends to exercise regulatory oversight over a mobile medical app that meets the definition of a medical device as defined in Section 201(h) of the Federal Food Drug and Cosmetic Act (FDCA):
An instrument, apparatus, implement, machine, contrivance, implant, in vitro regent, or other similar or related article, including any component, part or accessory, which is … intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals, or … intended to affect the structure or any function of the body of man or other animals …
And, either is used as an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device.
As explained in the draft guidance, the intended use of a mobile app determines whether it meets the definition of a device. Intended use, as stated in 21 CFR 801.4, may be shown by labeling claims, advertising materials, or oral or written statements by manufacturers or their representatives. When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device. If a mobile app is intended for use in performing a medical device function, it is a medical device, regardless of the platform on which it is run.
If the app does not fit into one of the above two categories, the FDA intends to exercise its enforcement discretion and refrain from active regulation. However, the FDA states it will monitor these apps and determine whether additional or different actions are necessary to protect the public health. The FDA notes that manufacturers may, at their discretion, elect to register and list, and to seek approval or clearance for these mobile apps with the FDA, and further reminds all mobile app manufacturers whose apps meet the device definition, that the Agency strongly recommends that to prevent patient and user harm, the manufacturer follow the Quality Systems regulations in 21 C.F.R. Part 820 and initiate prompt corrections to their mobile medical apps, when appropriate.
In addition to mobile medical apps intended to fall within the scope of regulation, the guidance includes examples of several categories of mobile medical apps the FDA plans to exclude from regulation.
Who is expected to comply
Manufacturer of a mobile medical app
Mobile platform manufacturer
Regulatory requirements for mobile medical apps
According to the draft guidance, mobile medical app manufacturers must meet the requirements associated with the applicable device classification, and although no specific process is described in the draft document to gain FDA input in a timely manner, the FDA encourages manufacturers to contact the Agency to determine the classification of their mobile medical app. If the app itself falls within a medical device classification, the manufacturer must meet the requirements associated with that class. If the app adds medical device functionality to a mobile platform, the manufacturer must meet the classification requirements applicable to that functionality. The draft guidance describes four categories that identify the types of mobile medical apps and for each, the associated classifications:
What can we expect?
The issuance of a draft Guidance to Industry marks the FDA’s intention to regulate the mobile medical environment. The importance of a clear and predictable outline of the expectations of the Agency is critical given research projections that hundreds of millions of smartphone users worldwide will be using a healthcare application by 2015. The draft guidance provides the most comprehensive source of the FDA’s views on the application of the FDCA to mobile apps, but it also raises a number of significant questions and is ambiguous in certain respects. One comprehensive source where concerns are expressed is the response comment filed by mHealth Regulatory Coalition, a temporary organization of industry representatives comprised of medical device manufacturers, mobile app developers, online marketplaces for mobile apps, mobile platform manufacturers, telecommunications service providers, and information and communications technology companies. (See http://mHealthregulatorycoalition.org.) While the details of FDA’s regulatory approach remain in flux, the draft guidance serves as notification that some mobile medical apps are, in the FDA’s view, subject to regulation. Final guidance is expected in early 2012.
As chair of Stradley Ronon Stevens & Young, LLP’s Life Sciences Practice Group, Debra Dunne counsels FDA-regulated companies on regulatory, commercial, compliance and risk-management issues, and litigates pharmaceutical and medical device commercial and products liability cases. Her practice includes working on cross-functional client teams on complex legal and regulatory issues related to drug development and post-marketing, including REMS evaluation and planning, FDA advisory board preparation, safety, promotional and scientific reviews. She is a frequent speaker and was a pharmacist prior to getting her law degree.
Julia M. Rafferty is an attorney of Stradley Ronon Stevens & Young, LLP, where she focuses on general litigation, primarily in the area of products liability and mass tort. She is a member of the firm’s life sciences practice group, which offers extensive experience representing pharmaceutical, medical device and other FDA-regulated companies. Rafferty is dedicated to her involvement in the community. She currently serves as a member of the board of trustees at the Gesu School in Philadelphia and serves on the National Alumni Council of Notre Dame Academy. Rafferty graduated with a B.S. from Boston College and received her J.D. from Villanova University School of Law.